Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-04-05
2019-10-20
Brief Summary
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Detailed Description
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The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.
All of the patients were selected according to the study inclusion and exclusion criteria.
Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.
The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.
Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.
The patients who did not show in all the study follow up's appointments were dropped from the data analysis.
Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
-Group B: was treated with diode 940 nm Laser.
TREATMENT
QUADRUPLE
Participants, investigator, the tree external clinical examiners were blinded about the allocation of the patient in the treatment group.
Care provider didn't interfere in collecting and analysing the data.
Study Groups
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Er,Cr:YSGG laser 2780 nm
Group A was treated by an Er,Cr:YSGG laser 2780 nm cylindrical tip (tip 600 μm, 45 millijoule /pulse, average power 2.25 W, frequency 50 Hz, pulse duration 60 µs, energy density 43 J/cm2, water 50%, and air 40%). The procedure was performed completely without anesthesia with the laser tip at angulation \~30° and distance of \~1 mm from the gingival tissue. The laser tip was advancing in scanning movement from in the cervical-apical direction in all pigmented areas. The following settings was used to achieve hemostasis in case of the bleeding was present (tip 600 μm, 30 millijoule /pulse, average power 1.5 W, frequency 50 Hz, pulse duration 700 µs, energy density 28.7 J/cm2, water 10%, and air 20%).
Er,Cr:YSGG laser 2780 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Diode laser 940 nm
Group B was treated with diode 940 nm Laser. The procedure was performed with a pencil-sized handpiece containing a 400 µm lasing fiber (400 μm initiated tip, average power 0.8 watts, Pulsed mode, Duty cycle 20%, Pulse duration 10 μs, energy density 636.9 J/cm2 per second, no water or air). Infiltration anesthesia was injected for B group . The laser tip was placed in angle \~30° with the gingival surface. Short light paint brush strokes were used in the cervical-apical direction in all pigmented areas.
Diode laser 940 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Interventions
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Er,Cr:YSGG laser 2780 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Diode laser 940 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
* Pregnancy and lactation
* History of smoking
* Previous mucogingival surgery at the region to be treated
* No contraindication for the laser treatment.
20 Years
ALL
Yes
Sponsors
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Damascus University
OTHER
Academy of Laser Dentistry - Gulf Laser Chapter
OTHER
Responsible Party
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Principal Investigators
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Omar Hamadah, PhD
Role: STUDY_DIRECTOR
Damascus University
Locations
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Dr. Tamim Dental Polyclinic
Doha, , Qatar
Countries
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References
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Simsek Kaya G, Yapici Yavuz G, Sumbullu MA, Dayi E. A comparison of diode laser and Er:YAG lasers in the treatment of gingival melanin pigmentation. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Mar;113(3):293-9. doi: 10.1016/j.tripleo.2011.03.005. Epub 2011 Jun 12.
Nammour S, El Mobadder M, Namour M, Namour A, Rompen E, Maalouf E, Brugnera Junior A, Brugnera AP, Vescovi P, Zeinoun T. A Randomized Comparative Clinical Study to Evaluate the Longevity of Esthetic Results of Gingival Melanin Depigmentation Treatment Using Different Laser Wavelengths (Diode, CO2, and Er:YAG). Photobiomodul Photomed Laser Surg. 2020 Mar;38(3):167-173. doi: 10.1089/photob.2019.4672. Epub 2020 Jan 17.
Hegde R, Padhye A, Sumanth S, Jain AS, Thukral N. Comparison of surgical stripping; erbium-doped:yttrium, aluminum, and garnet laser; and carbon dioxide laser techniques for gingival depigmentation: a clinical and histologic study. J Periodontol. 2013 Jun;84(6):738-48. doi: 10.1902/jop.2012.120094. Epub 2012 Sep 24.
Other Identifiers
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GulfLaserChapter
Identifier Type: -
Identifier Source: org_study_id